Crohn's DiseaseNCT01813500
Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients
An observational study of Crohn's Disease and Ulcerative Colitis, run by Boston Medical Center at 1 site in United States.
Trial summary
The inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn's disease (CD) are chronic conditions affecting approximately 1.4 million Americans. The burden of Clostridium difficile infection (CDI), a frequent cause of infectious diarrhea is mediated by toxins A and B and is increasing faster in IBD… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis, Clostridium Difficile
- What is being tested?
- Blood and stool sample
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with Crohn's Disease and Ulcerative Colitis or healthy controls.
Who may be able to join
- All subjects must be 18 years of age or older, able to provide written informed consent, and able to comply with the requirements of the study.
- All subjects must speak English. Non-English subjects are not included because of lack of funding for interpreter services and clinical resources could not be used for research purposes.
- For Control Group only: Non-IBD subject seen in CDD during routine visit or on inpatient consult service
- For IBD Group Only: Chart history of IBD (either UC or CD) confirmed by colonoscopy, pathology or gastroenterology clinical judgment
Who cannot join
- Any subject planning on moving out of the area in the next year
- Any patient not able to give informed consent
- Any subject unwilling or not able to give stool sample upon enrollment
Trial locations and contacts
1 site in 1 country.
About this study
The inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn's disease (CD) are chronic conditions affecting approximately 1.4 million Americans. The burden of Clostridium difficile infection (CDI), a frequent cause of infectious diarrhea is mediated by toxins A and B and is increasing faster in IBD patients, than the general population. Clinically, CDI in patients with IBD leads to a range of clinical syndromes from symptomless carriage, to severe life threatening colitis, colectomy and death.
This pilot study will look at the relationship between IBD and this variable host immune response. Clostridium difficile colonization (asymptomatic carrier state) is lower in the IBD population than in the general population. In the general population, high antitoxin titers have been linked with colonization and low antitoxin titers with recurrent disease. The investigators hypothesize that patients with IBD will have a lower Clostridium difficile colonization and will have lower antibody titers than the control group. Additionally those with lower titers will have an increased risk of developing CDI.
In Aim 1 the investigators will determine Clostridium colonization in IBD subjects by stool study (including CD, UC and UC patients after IPAA) compared to non-IBD subjects (controls). In Aim 2 the investigators will compare antitoxin titers in these IBD subjects compared to controls. In Aim 3 the investigators will follow these subjects for 12 months and calculate the incidence of CDI in patients with IBD compared to controls and associations with anti-toxin titers.
Read the detailed description
This is a two part pilot study, with the initial phase (Aim 1 and Aim 2) being a cross-sectional epidemiological analysis of Clostridium difficile colonization and anti-toxin antibodies in the IBD population compared to non-IBD patients.
The second phase (Aim 3) is a pilot nested case-control study that will follow both groups of patients prospectively for 12 months to see who develops either colonization or active CDI and correlate these to clinical demographics and serum Clostridium difficile anti-toxin antibodies.
All subjects age eighteen and older who are able to give consent, have a diagnosis of inflammatory bowel disease (see clinical definition of IBD below) and are followed in the Center for Digestive Disease (CDD) are eligible for this study. Control subjects will also be followed in the CDD without a diagnosis of IBD. All subjects will be recruited from routine scheduled visits when seen as outpatients at the CDD or will be identified from the inpatient Gastroenterology consult service or at the Internal Medicine Department at Shapiro as part of Dr. Qazi's rotation(see recruitment section).
Subjects will be recruited in a block fashion to minimize confounding variables and ensure groups with equal amount of diarrhea and to keep a 3:1 ratio of IBD to controls. Subject will be recruited on a consecutive basis in a block of 32 slots. Within that block, 8 slots will be for the control group (4 with diarrhea, 4 without) and 24 IBD patients (12 with diarrhea, 12 without). Once all slots are filled then the next block will begin.
For Aim 1 and Aim 2: Upon enrollment subjects from both groups will provide blood and stool samples (details of amount and timing discussed below) and a retrospective chart review will document pre-determined data (as listed below). Total time requirement upon enrollment would be about 10-15 minutes.
For Aim 3: This is an intention-to-treat analysis; control subjects who become diagnosed with IBD during the study period will be kept in the control group. Patients will be followed for a 12 month period:
If during that time there is no CDI then there will be no further study visits, only data review at the end of the study period.
If a subject develops diarrhea in either group, treatment will be per standard of care (detailed below) and research team will be alerted by primary Gastroenterologist or GI consult team. If deemed appropriate by clinical team stool will be sent for C diff (per SOC) and if positive, then repeat blood samples for anti-toxin titers may be collected (for research purposes). At the end of the 12 month study period data will be reviewed.
- Being tested
- Blood and stool sample
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and stool sampleOther
Subjects are asked to provide a blood sample (6 to 10cc) and a stool sample. An additional blood sample will be requested if the subject has a flare.
| Study group | Role | What they receive |
|---|---|---|
| IBD Patients | Subjects with Crohn's Disease or Ulcerative colitis. IBD patients will be asked to provide a blood and stool sample. Receives: Other: Blood and stool sample | |
| Control Subjects | Subjects without Crohn's Disease or Ulcerative Colitis. Controls will also be asked to provide a blood and stool sample. Receives: Other: Blood and stool sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonization
Determine Clostridium colonization in IBD patients during clinical remission and during flares (including CD, UC and UC patients after IPAA) compared to controls
Measured: 12 Months
Secondary outcomes (1)
Incidence
Determine the incidence of CDI in patients with IBD (including CD, UC and UC patients after IPAA) compared to controls and correlate to anti-toxin titer levels using the methods as outlined above
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startOct 2011
- Primary completionSep 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cepheid, Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Responsible party
- Principal investigator, Francis Farraye, MD, Boston Medical Center
- Investigators
- Francis A Farraye, MD, Principal investigator, Boston Medical Center Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813500
- Sponsor's protocol ID
- H-31226
- Status last verified
- Apr 2017
- First submitted
- 15 Mar 2013
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Berg AM, Kelly CP, Farraye FA. Clostridium difficile infection in the inflammatory bowel disease patient. Inflamm Bowel Dis. 2013 Jan;19(1):194-204. doi: 10.1002/ibd.22964.
PubMed 22508484
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients
- ClinicalTrials.gov ID
- NCT01813500
- Acronym / sponsor ID
- H-31226
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Cepheid, Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Study start
- Oct 2011 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn's disease (CD) are chronic conditions affecting approximately 1.4 million Americans. The burden of Clostridium difficile infection (CDI), a frequent cause of infectious diarrhea is mediated by toxins A and B and is increasing faster in IBD patients, than the general population. Clinically, CDI in patients with IBD leads to a range of clinical syndromes from symptomless carriage, to severe life threatening colitis, colectomy and death.
This pilot study will look at the relationship between IBD and this variable host immune response. Clostridium difficile colonization (asymptomatic carrier state) is lower in the IBD population than in the general population. In the general population, high antitoxin titers have been linked with colonization and low antitoxin titers with recurrent disease. The investigators hypothesize that patients with IBD will have a lower Clostridium difficile colonization and will have lower antibody titers than the control group. Additionally those with lower titers will have an increased risk of developing CDI.
In Aim 1 the investigators will determine Clostridium colonization in IBD subjects by stool study (including CD, UC and UC patients after IPAA) compared to non-IBD subjects (controls). In Aim 2 the investigators will compare antitoxin titers in these IBD subjects compared to controls. In Aim 3 the investigators will follow these subjects for 12 months and calculate the incidence of CDI in patients with IBD compared to controls and associations with anti-toxin titers.
Detailed description
This is a two part pilot study, with the initial phase (Aim 1 and Aim 2) being a cross-sectional epidemiological analysis of Clostridium difficile colonization and anti-toxin antibodies in the IBD population compared to non-IBD patients.
The second phase (Aim 3) is a pilot nested case-control study that will follow both groups of patients prospectively for 12 months to see who develops either colonization or active CDI and correlate these to clinical demographics and serum Clostridium difficile anti-toxin antibodies.
All subjects age eighteen and older who are able to give consent, have a diagnosis of inflammatory bowel disease (see clinical definition of IBD below) and are followed in the Center for Digestive Disease (CDD) are eligible for this study. Control subjects will also be followed in the CDD without a diagnosis of IBD. All subjects will be recruited from routine scheduled visits when seen as outpatients at the CDD or will be identified from the inpatient Gastroenterology consult service or at the Internal Medicine Department at Shapiro as part of Dr. Qazi's rotation(see recruitment section).
Subjects will be recruited in a block fashion to minimize confounding variables and ensure groups with equal amount of diarrhea and to keep a 3:1 ratio of IBD to controls. Subject will be recruited on a consecutive basis in a block of 32 slots. Within that block, 8 slots will be for the control group (4 with diarrhea, 4 without) and 24 IBD patients (12 with diarrhea, 12 without). Once all slots are filled then the next block will begin.
For Aim 1 and Aim 2: Upon enrollment subjects from both groups will provide blood and stool samples (details of amount and timing discussed below) and a retrospective chart review will document pre-determined data (as listed below). Total time requirement upon enrollment would be about 10-15 minutes.
For Aim 3: This is an intention-to-treat analysis; control subjects who become diagnosed with IBD during the study period will be kept in the control group. Patients will be followed for a 12 month period:
If during that time there is no CDI then there will be no further study visits, only data review at the end of the study period.
If a subject develops diarrhea in either group, treatment will be per standard of care (detailed below) and research team will be alerted by primary Gastroenterologist or GI consult team. If deemed appropriate by clinical team stool will be sent for C diff (per SOC) and if positive, then repeat blood samples for anti-toxin titers may be collected (for research purposes). At the end of the 12 month study period data will be reviewed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD Patients | – | Other: Blood and stool sampleSubjects with Crohn's Disease or Ulcerative colitis. IBD patients will be asked to provide a blood and stool sample. |
| Control Subjects | – | Other: Blood and stool sampleSubjects without Crohn's Disease or Ulcerative Colitis. Controls will also be asked to provide a blood and stool sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with Crohn's Disease and Ulcerative Colitis or healthy controls.
Key inclusion criteria (4 listed)
- All subjects must be 18 years of age or older, able to provide written informed consent, and able to comply with the requirements of the study.
- All subjects must speak English. Non-English subjects are not included because of lack of funding for interpreter services and clinical resources could not be used for research purposes.
- For Control Group only: Non-IBD subject seen in CDD during routine visit or on inpatient consult service
- For IBD Group Only: Chart history of IBD (either UC or CD) confirmed by colonoscopy, pathology or gastroenterology clinical judgment
Key exclusion criteria (3 listed)
- Any subject planning on moving out of the area in the next year
- Any patient not able to give informed consent
- Any subject unwilling or not able to give stool sample upon enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and stool sampleSubjects are asked to provide a blood sample (6 to 10cc) and a stool sample. An additional blood sample will be requested if the subject has a flare. | Other | Control Subjects, IBD Patients |
Primary outcome
Colonization
Time frame: 12 Months
Determine Clostridium colonization in IBD patients during clinical remission and during flares (including CD, UC and UC patients after IPAA) compared to controls
1 secondary outcome
Incidence
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Background: PubMed 22508484Berg AM, Kelly CP, Farraye FA. Clostridium difficile infection in the inflammatory bowel disease patient. Inflamm Bowel Dis. 2013 Jan;19(1):194-204. doi: 10.1002/ibd.22964.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis A Farraye, MD principal investigator
Boston Medical Center Department of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Ulcerative Colitis, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonization (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01813500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017; AzTrials last refreshed its copy on 26 Oct 2026.